Unicycive Therapeutics Announces Exclusive License and Development Agreement with Lee’s Pharmaceutical Holdings Limited for Renazorb in China and Certain Other Asian Markets – Form 8-K

Unicycive Announces Exclusive License and Development Agreement with
Lee’s Pharmaceutical Holdings Limited for Renazorb in China and certain other Asian markets

Expands and accelerates Renazorb’s opportunity in important patient markets
hyperphosphatemia thanks to a local partner with in-depth expertise in the field

Agreement includes upfront payment, royalties and milestone payments

LOS ALTOS, Calif., July 18, 2022 — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the Company has entered into an agreement granting the exclusive rights to develop, marketing and commercialization of Renazorb® (lanthanum dioxycarbonate) to Lee’s Pharmaceutical (HK) Limited, a wholly owned subsidiary of Lee’s Pharmaceutical Holdings Limited (“Lee’s Pharm”) (SEHK: 950), in Mainland China, Hong Kong and in some other Asian markets. Renazorb is Unicycive’s new phosphate-binding agent under development for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD).

“We are delighted to partner with Lee’s Pharm for the development and commercialization of Renazorb in China, one of the world’s largest end-stage renal disease (ESRD) markets, where we believe our novel phosphate-binding agent will bring significant benefits to patients with hyperphosphatemia,” said Shalabh Gupta, MD, President and CEO of Unicycive. “Lee’s Pharm has the clinical, regulatory and commercial expertise in these Asian markets and we are confident that this relationship will maximize market opportunities for our proprietary nanotechnology-based asset in these territories while delivering significant benefits to patients. Unicycive owns the global rights for Renazorb and by partnering with Renazorb in select Asian countries, we are beginning to unlock its value for patients, physicians and for our shareholders.”

Under the terms of the agreement, Lee Pharm will be responsible for the development, registration and approval of Renazorb in the licensed territories. In addition, Lee Pharm will be solely responsible for the importation of Unicicive’s drug product and the costs of marketing Renazorb in licensed territories.

Unicycive will receive an upfront payment of $1.0 million upon signing and up to $1.0 million in milestone payments upon product launch in China and will be eligible for tiered royalties upon achievement of regulatory achievements and commercial predefined.

“The global kidney disease market in Asia is growing due to the increase in chronic kidney disease and, in turn, is leading to an increase in the incidence of hyperphosphatemia. as patient compliance is an important factor in achieving target serum phosphorus levels. Uncontrolled hyperphosphatemia is a persistent challenge leading to increased hospitalizations and increased risk of mortality,” said Ms. Leelalertsuphakun Wanee, Managing Director of Lee’s Pharm. “Renazorb also provides the commercial team at Lee’s Pharm with another product from our portfolio for sale in Asian markets.”

The incidence and prevalence of ESRD in China are expected to increase by 1.19 and 1.95% per year to reach 250.5 per million population (pmp) (95% CI, 247.7-253, 3) and 1505 pmp (95% CI 1450-1560) by 2025.I In patients with ESRD, the prevalence of hyperphosphatemia ranges from 50% to 74%.ii

I

BMC Nephrol. 2016 Jun 13;17(1):60. doi: 10.1186/s12882-016-0269-8.

ii

Leaf DE, Wolf M. A physiological approach to the evaluation of a patient with hyperphosphatemia. Am J Kidney Dis. 2013 Feb;61(2):330-6. [PMC free article] [PubMed]

About Renazorb (Lanthanum Dioxycarbonate)

Renazorb is a next-generation lanthanum-based phosphate-binding agent using proprietary nanoparticle technology under development for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). Its potential best-in-class profile has significant patient compliance advantages over currently available treatment options, as it requires fewer and fewer pills per dose and is swallowed instead of be chewed.

About Hyperphosphatemia

Hyperphosphatemia is a serious medical condition that occurs in almost all patients with end-stage renal disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then leads to renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures, and bone pain); cardiovascular disease associated with hardening of the arteries and atherosclerosis (due to the deposition of excess calcium-phosphorus complexes in soft tissues).

Importantly, hyperphosphatemia is independently associated with increased mortality in patients with chronic renal failure on dialysis. According to the clinical data available to date, more than 80% of patients show signs of cardiovascular calcification at the time they become dependent on dialysis.

Dialysis patients are already at increased risk of cardiovascular disease (due to underlying conditions such as diabetes and hypertension), and hyperphosphatemia further compounds this risk. Treatment of hyperphosphatemia aims to lower serum phosphate levels by two means: (1) restricting dietary phosphorus intake; and (2) using, daily and at each meal, oral phosphate-binding drugs that facilitate faecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Lee’s Pharm

Lee’s Pharm is a research-driven and market-driven biopharmaceutical company with more than 25 years in the pharmaceutical industry in China. Lee’s Pharm is fully integrated with strong infrastructure in drug development, clinical development, regulatory, manufacturing, sales and marketing based in Mainland China with global outlook. Lee’s Pharm has established extensive partnerships with over 20 international companies and currently markets over 25 proprietary, generic and licensed pharmaceutical products in Mainland China, Hong Kong, Macau and Taiwan. The Company focuses on several key disease areas such as cardio-renal, women’s health, pediatrics, rare diseases, oncology, dermatology and obstetrics, and has more than 40 products in various stages of development from both in-house research and development as well as the licensing of development, marketing, and manufacturing rights to various U.S., European, and Japanese companies. More information is available at www.leespharm.com.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing new treatments for kidney disease. Unicycive’s lead drug, Renazorb, is a new phosphate-binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, visit www.unicycive.com.

Forward-looking statement

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be identified by words such as “anticipate”, “believe”, “expect”, “estimate”. ‘ and ‘intend’. ” or other similar words or expressions that relate to Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. Many factors could cause cause actual events to differ materially from those indicated by these forward-looking statements.These factors include, but are not limited to, clinical trials involving a long and expensive process with an uncertain outcome, and the results of studies and prior trials may not be predictive of future trial results; our clinical trials may be suspended or terminated due to unexpected side effects or other safety risks that may prevent approval of our product candidates; risks related business interruptions, including the COVID-19 coronavirus outbreak, which could seriously harm our business financial situation and increase our costs and expenses; reliance on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence on third parties; and risks related to the inability to obtain FDA clearances or approvals and non-compliance with FDA regulations. Actual results may differ materially from those indicated by these forward-looking statements due to a variety of important factors, including: uncertainties related to market conditions and other factors described in more detail in the section entitled “Risk Factors” of the annual report of Unicycive on Form 10-K for the fiscal year ended December 31, 2021 and other periodic reports filed with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or other.

Investor contacts:

[email protected]

(650) 900-5470

Anne-Marie Fields

Serious investor relations

[email protected]

212-362-1200

SOURCE: Unicycive Therapeutics, Inc.

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